Senior Quality Control Analyst

Join Immatics and shape the future of cancer immunotherapy; one patient at a time!

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Why Join Us?

• Innovative Environment: Help to pioneer advancements in cancer immunotherapy.
• Collaborative Culture: Be part of a diverse team dedicated to your professional growth.
• Global Impact: Contribute to therapies that make a lasting impact on patients globally.

We are seeking a Senior Quality Control Analyst to join our Global Quality Operations team. In this role, the Senior Quality Control Analyst will be responsible for performing bioanalytical, cell-based, and molecular assays to support product release and stability testing within the Quality Control laboratory. The position will also play a key role in method transfer, qualification, and validation activities.

FLSA Classification: Salary, Exempt

Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-site

Reports to: Quality Control Manager

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

What You’ll Do:

As a Senior Quality Control Analyst, you will play a key role in supporting our Quality Control Operations:

Conduct Tests and Analyze Results: Perform routine and non-routine testing on products and materials to verify compliance with established standards.

Collaboration: Manage, in collaboration with other team members, purchasing, receiving, formulating, testing, release of materials and reagents, equipment and assay qualifications and validation.

Quality Records: Lead quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.

Documentation:

• Author and conduct periodic review of procedures.
• Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures.
• Maintain data integrity and logs for equipment.

Data Analysis: Ability to analyze complex data sets and interpret results accurately. Able to identity trend and deviations, and take initiative to troubleshoot issues

Manage Laboratory Equipment: Perform and oversee the maintenance and calibration of laboratory equipment.

Ensure Compliance: Involved in the creation of systems used in quality control to maintain compliance with regulations.

Safety: Always demonstrate good safety practices and promote safety awareness.

Secondary Functions:

• Train and support junior analysts.
• Transport controlled documents, QA-released QC materials and human biological samples.
• Assist with group tasks scheduling
• Maintain knowledge of internal procedures and current regulatory requirements

Required Experience and Education:

• BA or BS in any science-related field
• Minimum five (5) years experience in a regulated laboratory environment
• MS degree or specialized skill set may substitute for 3 years
• Experience as a QC personnel in a related field.
• Experience in aseptic technique, cell culture and either flow cytometry or cell-based assays.

Preferred Experience and Education:

• MS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical
• Science/Engineering
• Minimum five (5) years experience in a regulated laboratory environment
• Laboratory skills include a few of the following: visual inspection, flow cytometry,
• molecular and cell-based assays.
• Demonstrate technical competence and knowledge in method transfer and assay
• qualification/validation activities
• Excellent technical writing and troubleshooting/investigational skills.
• Demonstrate knowledge of cGMP/ICH/EU regulations and requirements.
• Experience writing GxP deviations, lab investigations, OOS/OOE, CAPAs, change
• controls, etc.
• Experience with LIMS and statistical software is a plus

Competencies:

• Initiative
• Problem Solving
• Very detail oriented
• Strong analytical
• Technical writing, verbal communication, and interpersonal skills
• Ability to work Independently and manage multiple projects with aggressive timelines

Work Environment:

• This position works in a typical office and lab environment with moderate noise

levels and uses phone, computer, office equipment and supplies on a regular basis.

Other duties performed while outside of office and lab building could involve

exposure to manufacturing operations, along with outdoor conditions (including

highway traffic) and temperatures.

• The percentage of working hours spent in a typical office and/or laboratory

environment varies based on business needs.

• While performing the duties of this job, the employee may be occasionally exposed

to moving mechanical parts, fumes or airborne particles, pathogens, and toxic or

caustic chemicals. The employee can be occasionally exposed to wet and/or humid

conditions, risk of electrical shock, sharps, or cuts, while performing tests. This

position requires handling of human biological specimens including human

peripheral blood and human T cell products, as well as laboratory chemicals

Travel required: Less than 10% Minimal

Physical demands:

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.
• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
• Pushing - Exerting force upon an object so that the object moves away from the object.
• Pulling - Exerting force upon an object so that the object moves toward the force.
• Sitting – remaining in a sitting position for at least 50% of the time.
• Standing/Walking - remain on one's feet in an upright position at a workstation.
• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Work authorization/security clearance requirements:

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment

Affirmative Action/EEO statement:

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin,

ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic

information, gender, sexual orientation, gender identity or expression, veteran status, or any

other status protected under federal, state, or local law.

What do we offer?

At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics

Comprehensive Benefits:

• Competitive rates for Health, Dental, and Vision Insurance
• 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
• Sick Time Off – 56 hours
• 12 Paid Holidays
• 100% Employer-Paid Life Insurance up to at 1x annual salary
• 100% Employer Paid Short- and Long-Term Disability Coverage
• 401(k) with Immediate Eligibility & company match…
• You are eligible for 401(k) plan participation as of your first paycheck.
• The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
• Partially paid Parental Leave for eligible employees. (3 weeks)
• Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.

Professional Growth:

• Opportunities to work with leading experts in the field of T-cell immunotherapy.
• Company provided learning and development opportunities
• Fast paced, high demand collaborative and dynamic environment.